Note: Descriptions are shown in the official language in which they were submitted.
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AUTOMATIC MEDICATION INJECTION DEVICE WITH VISIBLE
INDICATION OF INJECTING PROGRESS
BACKGROUND OF THE INVENTION
The present invention pertains to medication injection devices, and, in
particular,
to medication injection devices having features that provide to the users of
such devices
visible infotmation as to use.
Patients suffering from a number of different diseases frequently must inject
themselves with medications. A variety of devices have been proposed to
facilitate these
injections. One type of device is an automatic medication injection device.
This type of
device typically includes a trigger that when operated by a user causes the
device to
automatically insert into the user a needle of a syringe that prior to
triggering was
disposed within the device housing, and then the device automatically injects
a dose of
medication through that inserted needle. In some cases, an automatic injection
device
does not so insert the needle into the user, but does, when triggered,
automatically inject a
dose of medication through the needle that has been manually inserted by the
user.
One potential shortcoming with using automatic injection devices relates to
the
fact that some users may be unsure they are using the devices correctly.
Without some
sort of feedback from the device when it is being used, a user may question
whether an
injection has commenced or whether it is finished. Uncertainty in the user
about an
injection being completed is particularly likely in cases where the injection
takes a
relatively long time to complete, possibly such as due to a large volume dose
or a high
viscosity dose of medication being delivered.
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Some known devices such as disclosed in WO 2014/053496 and US
2013/0317434 provide visual indicators associated with device use. However,
known
indicators that do not provide sufficient updates during a medication
injection,or that rely
on a user looking for a portion of a sealing plunger that resides within a
cartridge or fluid
container barrel, may not be adequate or convenient for some users.
Thus, it would be desirable to provide an automatic medication injection
device
with a visible indicator which can overcome one or more of these and other
shortcomings
of the prior art.
BRIEF SUMMARY OF THE INVENTION
In one form thereof, the present invention provides an automatic medication
injection device including a user grippable housing, a container of
medication, a drive
mechanism and a plurality of injecting progress indicators. The user grippable
housing
has a length extending in an axial direction between a proximal end and a
distal end. The
container of medication includes an outlet that is disposed proximally of the
housing
proximal end at least during injection. The container includes a barrel and a
sealing
plunger, which sealing plunger is in sealing engagement with the barrel. The
drive
mechanism is within the housing and when triggered automatically advances the
sealing
plunger proximally within the container to force medication from the container
outlet.
The plurality of injecting progress indicators are visible along a periphery
of the housing.
At least one of the plurality of injecting progress indicators is located
distally of the
container during an injection. The injecting progress indicators include a
flag element
movable as the drive mechanism advances the sealing plunger proximally within
the
container. The plurality of injecting progress indicators are configured to
indicate
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sequentially in an axial direction during a single injection as the flag
element moves to
cooperatively complete different injecting progress indicators at different
times during the
single injection, whereby injecting progress of the injection may be monitored
by a user.
One advantage of the present invention is that an automatic medication
injection
device may be provided with a visible indicator of injecting progress.
Another advantage of the present invention is that an automatic medication
injection device may be provided with a visible indicator of injecting
progress that
updates during the medication delivery.
Still another advantage of the present invention is that an automatic
medication
injection device may be provided having a visible indicator of injecting
progress that is
easily readable due to its form as well as its positioning within the device
housing.
BRIEF DESCRIPTION OF THE DRAWINGS
The above-mentioned and other advantages and objects of this invention, and
the
manner of attaining them, will become more apparent, and the invention itself
will be
better understood, by reference to the following description of embodiments of
the
invention taken in conjunction with the accompanying drawings, wherein:
Fig. 1 is a front view of an automatic injection device with a visible
injecting
progress indicator of the present invention shown prior to use;
Fig. 2 is a cross-sectional side view of the device of Fig. 1 prior to use,
wherein
portions of the device are omitted or shown schematically;
Fig. 3 is a cross-sectional side view of the device of Fig. 2 after triggering
and at a
point when the needle has been extended for user penetration but before the
start of the
medication dose actually injecting into the user through the needle;
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Fig. 4 is a schematic front view of the injecting progress indicators shown
separate
from the remainder of the device and as configured when the device is arranged
as in Fig.
3;
Fig. 5 is a schematic front view similar to the view of Fig. 4 but as
configured at a
later time during injection than as shown in Fig. 4;
Fig. 6 is a schematic front view similar to the view of Fig. 5 but as
configured at a
later time during injection than as shown in Fig. 5;
Fig. 7 is a schematic front view similar to the view of Fig. 6 but as
configured at a
later time during injection than as shown in Fig. 6;
Fig. 8 is a schematic front view similar to the view of Fig. 7 but as
configured at a
later time during injection than as shown in Fig. 7;
Fig. 9 is a schematic front view similar to the view of Fig. 8 but as
configured at a
later time at which the complete medication dose of the device has been
injected through
the needle;
Fig. 10 is a schematic front view of injecting progress indicators of an
automatic
injection device in another form of the present invention, which indicators
are configured
at an early stage of an injection;
Fig. 11 is a schematic front view similar to the view of Fig. 10 but as
configured at
a later time during injection than as shown in Fig.10;
Fig. 12 is a schematic front view similar to the view of Fig. 11 but as
configured at
a later time at which the complete medication dose has been injected; and
Fig. 13 is an exploded view of select portions of an automatic medication
injection
which provide injecting progress indicators.
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Corresponding reference characters indicate corresponding parts throughout the
several views. Although the drawings represent embodiments of the present
invention,
the drawings are not necessarily to scale, and certain features may be
exaggerated or
omitted in some of the drawings in order to better illustrate and explain the
present
invention.
DETAILED DESCRIPTION OF THE INVENTION
Referring now to Figs. 1, 2 and 3, there are shown different views of a first
embodiment of an automatic medication injection device with injecting progress
indicators of the present invention. The automatic medication injection
device, generally
designated 20, is shown and described as a device that when its trigger is
manually
operated, its needled syringe 50 is automatically driven downward such that
its injection
needle projects beyond the bottom end of the device housing to penetrate the
user. The
device then proceeds to inject automatically, that is without further user
action, the entire
medication contents of the device through the injection needle.
The injecting progress indicators, generally indicated at 25, find beneficial
application in the device 20 described herein, but such application is merely
illustrative
and not intended to be limiting. The injecting progress indicators can be used
in many
different types of automatic medication injection devices where its benefits
are desired,
including devices in which the insertion of the needle is manually performed
but the
forcing of the medicine through such needle is automatic once triggered, and
in devices in
which more than a single dose is dispensable therefrom.
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It will be appreciated from the following description that device 20 is
conceptually
similar in various aspects to the devices disclosed in International
Publication Number
WO 2014/062488.
Device 20 includes an outer housing 23, which is grippable by a user and in
which
are operationally disposed working components of the device. The outer housing
23
includes a safety sleeve 26 and a main body 24 that together form the height
of the outer
housing extending in the axial direction between proximal end 28 and distal
end 30. l'he
main body 24 is shown formed of a transparent plastic, and an opaque wrap or
label 34
around the upper portion of the main body 24 hides working device components
protectively encased within the housing. Label 34 may include information,
such as icons
36 associated with locking, or product details or instructions for use. Label
34 includes a
slot or opening 38 through which injecting progress indicators 25 are visible
to a user of
device 20 along the exterior or periphery of the housing 23. Instead of an
opening 38, the
= label 34 instead could be transparent at that region.
Safety sleeve 26 is rotatable by the user relative to main body 24 between
locked
and unlocked conditions as indicated at icons 36. A button 40 that is part of
the trigger
assembly protrudes in the axial direction from the top or distal end 30 of the
housing.
When properly rotationally oriented by rotation of sleeve 26, button 40 is
unlocked such
that it can be depressed in the proximal direction to start the automatic
injection function
of device 20. As used herein, distal and proximal refer to axial locations
relative to an
injection site when the device is oriented for use at such site, whereby, for
example,
proximal end of the housing refers to the housing end that is closest to such
injection site.
The shown triggering button 40 is the manner in which device 20 is triggered,
but other
triggering designs are known and can be used in devices with injecting
progress
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indicators. A needle cap that is typically provided on device 20 and then
removed prior to
use is not shown in the Figures.
As further shown abstractly in Fig. 2, device 20 includes a medication-filled
container provided in the form of a syringe, generally designated 50, that is
axially
movable within the housing 23. Syringe 50 is of a conventional design and
includes a
transparent barrel 52 with a flange 54 at its distal end, an injection needle
56 that serves as
an outlet for the barrel 52, and a sealing plunger 58. Injection needle 56 is
mounted at the
proximal end of barrel 52 and in fluid communication with the medication
contents of the
barrel. Sealing plunger 58 is an elastomeric sealing member having an outer
radial
.. periphery adapted to slidably and sealingly engage the inner circumference
or inner radial
periphery of the barrel 52 so as to seal medication within the barrel below
the proximal
face of the sealing plunger 58.
Syringe 50 is disposed completely within the housing main body 24 prior to use
near the proximal end 28 and is visible in part from the exterior through the
housing 23
below label 34. Prior to device 20 being used for an injection, and as shown
in Figs. 1
and 2, the syringe 50 is positioned such that the tip 57 of its needle 56 is
recessed within
the housing 23. During an injection as shown in Fig. 3, the proximal tip 57 is
shifted
proximally of the housing proximal end 28 for penetrating the user.
Device 20 may use a conventional mechanical drive mechanism to move the
.. syringe 50 from the retracted position shown in Figs. 1 and 2 to the
injecting position
shown in Fig. 3, and then to advance the sealing plunger 58 proximally within
barrel 52 to
force the medication through the outlet tip 57 of needle 56. The particulars
of the drive
mechanism described below are not material to the present invention, as the
injecting
progress indicators can be adapted for use with different such mechanisms.
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The drive mechanism of device 20 is abstractly shown in Fig. 2 at 60 as
including
an axially entending plunger element 62, a driver 65, and a trigger assembly
70 that
includes button 40. Plunger element 62 has an upper or distal end
diagrammatically
shown at 75 in Figs. 2 and 3 that is cooperatively designed with the trigger
assembly to be
axially retained by the trigger assembly 70 until release by the depressing of
button 40.
When the plunger element 62 is so released the driver 65, which may be a
compression
spring already under load, forces the plunger element 62 proximally. When
element 62 is
so moved, the rod-shaped drive portion 76 of plunger element 62 which fits
within the
container barrel 52 moves to have its proximal end 77 first close the shown
gap 79, and
.. then abut the sealing element 58. Then, the continued driving of plunger
element 62
proximally by driver 65 advances the sealing element 58 proximally relative to
the
housing 23 an identical amount. The movement of the plunger element 62 and
sealing
plunger 58 first shifts the entire syringe 50 to a needle inserted position
shown in Fig. 3 at
which further proximal movement of the syringe 50 is prevented. Further
movement of
plunger element 62 then advances the sealing plunger 58 proximally within the
barrel 52
to force medicine from the syringe through needle 56.
Other types of drive mechanisms, such as electromechanical or chemical
reaction
powered drive mechanisms that work when triggered to shift the plunger element
62 may
he employed with the progress indicators of the invention.
The injecting progress indicators 25 include both a flag element and a series
of
reference features that cooperate with the flag element to provide readily
observable
infoimation to a user. In the embodiment of Fig. 1, the reference features are
provided by
four distinct, rounded rectangular viewing windows 82, 83, 84 and 85 that are
identically
shaped and sized. In Figs. 2 and 3, these windows 82-85 are shown directly
formed in the
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housing for purposes of illustration, but are actually formed in foimed in an
opaque part
that is visible through the transparent housing 24 as described below with
reference to
Fig. 13. In an alternate embodiment in which the housing is formed of an
opaque
material, the windows can be formed by openings in the housing.
Windows 82-85 are spaced axially and in axial alignment. Windows 82-85 are
separated and partially defined by opaque bands 90, 91 and 92 of identical
shape and size.
Each of bands 90-92 is approximately half the axial height of each of windows
82-85 to
distinctly set the windows apart.
The flag element of indicators 25 which cooperatively functions with the
windows
82-85 is provided by a element that moves within device 20 in response to
operation of
drive mechanism 60. Flag element in Fig. 2 is formed by a surface 100 on the
radially
outward side of a rectangular bar 102. When passing within windows 82-85 from
the
perspective of a user, surface 100 is highly visible outside of device 20. For
example, the
surface 100 may be colored red if the portions of the device otherwise most
visible
through windows 82-85 prior to an injection are green. Surface 100 passes
through each
of windows 82-85 during use in the embodiment of Figs. 2-3 so as to serve as a
single or
common flag element for each of the reference features.
Bar 102 is integrally formed with the plunger element 62 that moves axially,
but
not rotationally, within housing 23. Bar 102 is in radially spaced
relationship with rod-
shaped drive portion 76 to provide a gap 104 in which the distal flanged end
of syringe
barrel 52 fits when the plunger element 62 completes its injecting stroke.
Viewing windows 82-85 are axially positioned within device 20 in view of the
location of flag element surface 100 immediately prior to the forced flow of
medication
through needle 56 and the length of the travel of flag element 100 as it moves
during the
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process of satisfactorily emptying the syringe 50 to complete a dose
injection. As plunger
element 62 and therefore flag element 20 do not rotate within the housing
during the
injection process, the viewing windows 82-85 are in axial alignment such as
shown in
Fig. 1. Such alignment can be modified if, for example, the travel of a member
on which
5 the flag element is provided is not completely axially during an
injection. Moreover, if
the angular span of the flag element is sufficient, the viewing windows 82-85
could also
be other than in a complete axial alignment, or in other words, they could be
angularly
offset from each other within the angular expanse of the flag element.
In the embodiment of Figs. 1-3, the viewing windows are four in number, with
10 viewing windows 82 and 83 being axially located entirely above the
syringe 50 prior to
syringe movement during the needle insertion process. After needle insertion,
syringe 50
is entirely proximal of each of windows 82-84. In alternate embodiments, more,
or fewer
windows could be provided, so long as such are not confusing to the user.
Still further,
although shown as being separate windows which are spaced by opaque portions
of the
material which defines the adjacent windows, the windows could instead be
replaced with
a single window having a series of conspicuous markings along the axial height
of the
window. Markings could be on a transparency that overlays the single window,
or could
be adjacent the window, but in either case would be pronounced so as to be
easily visible.
In Figs. 4-9, the manner in which windows 82-85 or injecting progress
indicators
25 appear to a user during the injection process is further illustrated. Fig.
4 shows the
injecting progress indicators as arranged when device 20 is as shown in Figure
3. Flag
element surface 100 is not visible to a user as it is disposed distally of all
of the viewing
windows 82-85 so as not to fill any portion thereof. As the injection
progresses, the flag
element surface 100 moves down or proximally within the housing 23
simultaneously
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with and in identical amount as the movement of plunger element 62. This
movement
causes the lower edge 101 of surface 100 to start to become visible within,
and to have
surface 100 appear to fill from above, upper window 82, all while leaving the
bottom
three windows 83-85 unfilled by surface 100. The movement of plunger element
62 is
continuous and non-indexed such that flag element surface 100 would appear to
steadily
move down to fill the window 82. When flag element surface 100 has moved down
such
that its bottom edge 101 reaches band 90, window 82 appears filled and the
indicators 25
appear as shown in Fig. 5.
As the plunger element 62 and flag element surface 100 continue to move
downward, surface 100 eventually begins filling window 83 from above, and then
when
window 83 is approximately halfway so filled the upper edge 103 of surface 100
becomes
visible within window 82 which results in surface 100 appearing to be leaving
or draining
from window 82. The movement continues until the indicators 25 appear as shown
in
Fig. 6.
This filling and unfilling pattern of the windows continues as shown in Figs.
7 and
8 up until the point the plunger element 62 has reached the end of its stroke
to complete
the medication delivery. As such point the injecting progress indicators 25
are configured
as shown in Figure 9 in which window 85 is completely filled by surface 100
and
windows 82-84 above are empty, or free, of surface 100. Because the flag
element 20 so
moves to fill the window and thereby cooperatively completes different
injecting progress
indicators at different times during the injection, the user will be able to
recognize the
changing status of the injection, and that when window 85 is filled the
injection is
complete.
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It will be appreciated that the shown filling and then unfilling of windows 82-
85 in
sequence is merely one way the injecting progress indicators of the present
invention may
appear to a user during use. For example, if the flag element surface is tall
enough, the
windows could appear to completely fill up with a vibrant color in sequence,
with no
emptying of that vibrant color from any window occurring. Moreover, in an
alternate
embodiment the flag element could cooperate with the windows so as to complete
a given
indicator by the flag element actually being absent from a window. For
example, the flag
element could initially fill all the windows prior to use and then appear to
complete a
window by the flag element unfilling such window as it moves axially in a
manner
conceptually similar to the arrangement shown in Figures 4 through 9. In such
an
embodiment, the windows would appear to have a color found on the surface 100
drain
therefrom.
In still another alternate embodiment shown in Figs. 10-12 in which related
parts
to the embodiment of Figs. 4-9 are denoted with a prime reference, the flag
element
surface 100' can be provided with first and second colors on different axial
portions
thereof. A first color 105 and a second color 106, such as green and red, are
respectively
provided on the proximal and distal halves of the outwardly facing surface
100'. The
arrangement of injecting progress indicators shown in Fig. 10 in which first
color 105
completely fills window 82' may he prior to device use, or occur shortly after
the
injection process starts as described with repect to Figs. 4-9.
As the injection process continues, the flag element 100' fills in succession
the
windows 82'-85' with first color 105 and then with second color 106 as
represented in
Fig. 11. When the injection is completed as shown in Fig. 12, the bottom
window 85' is
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completely filled with second color 106, and none of the first color 105 is
visible within
any window, to show an end of injection having been reached.
Referring to Fig. 13, there is shown an exploded perspective view of two
components of an injection device by which viewing windows 82-85 described
with
respect to device 20 are readily provided. These device components are related
to those
disclosed in International Publication No. WO 2014/062488 and are plunger
element 62
and a lower shuttle 150. Plunger element 62 is the same as shown in Figs. 2
and 3 and is
therefore referenced the same. Lower shuttle 150 is not shown in Figs. 2 and 3
and is a
part of a delayed syringe retraction feature that may be incorporated in
device 20. Lower
.. shuttle 150 is axially stationary within the device housing 23 during an
injection, but is
moved distally within the device housing after an injection is complete to
retract the
syringe 50 into the housing.
The windows 82-85 are provided as openings 140, 141, 142 and 143 formed in the
opaque lower shuttle 150. The plunger element 62 moves within lower shuttle
150
during injection such that bar 102 slides within a channel 154 radially inward
of the
openings 140-143. The lower shuttle 150 and its openings 140-142, and that
portion of
flag element 100 of bar 102 which is is directly radially inward of the
openings 140-143,
are visible to a user through label opening 38 and the transparent main body
24 of the
device housing 23. During an injection, flag member 100 appears to pass
through the
openings 140-143 to indicate injection progress to a user. When the injection
is
completed and after the shuttle lower 150 has moved distally within the
housing 23, the
opening 143 filled by the flag member 100, which serves as the filled window
85, is still
visible within the opening 38 provided in the label 34, albeit at a more
distal position than
prior to the injection.
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While this invention has been shown and described as having preferred designs,
the present invention may be modified within the spirit and scope of this
disclosure. For
example, while device 20 provides an automatic needle insertion feature and
thus the
syringe needle does not project below the proximal end until the device is
triggered, the
instant injecting progress indicators could be used with an automatic injector
in which the
needle projects below a housing before use so as to be manually inserted into
the user,
after which a triggering automatically injects the medicine through the
inserted needle.
Still further, although the medication injection device 20 is shown as
utilizing a container
in the form of a syringe having a single outlet needle, the device could
utilize different
medication containers within the scope of the invention. Moreover, rather than
a single
needle, different alternative outlets from the container may be utilized
within the scope of
the invention as its teachings have applicability to other injection devices.
This application is therefore intended to cover any variations, uses or
adaptations
of the invention using its general principles. Further, this application is
intended to cover
such departures from the present disclosure as come within known or customary
practice
in the art to which this invention pertains.
